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Renal Denervation for Resistant Hypertension (RDNP-2012-01)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01865240
Recruitment Status : Terminated (No new participants enrolled. Protocol has been superseded)
First Posted : May 30, 2013
Last Update Posted : November 5, 2018
Sponsor:
Information provided by (Responsible Party):
Baker IDI Heart and Diabetes Institute

Brief Summary:
This is a study investigating the effectiveness of renal denervation in lowering blood pressure in people whose blood pressure is not adequately controlled despite treatment with 3 or more blood pressure lowering drugs. The study is designed to compare the effects of renal denervation to a usual care group receiving additional blood pressure lowering drugs.

Condition or disease Intervention/treatment Phase
Hypertension Device: Renal Denervation Phase 4

Detailed Description:
Previous studies have shown that the renal denervation procedure is safe and effective in reducing blood pressure in patients with resistant hypertension. A total of 100 participants with uncontrolled blood pressure, treated with three or more blood pressure lowering medications will be recruited into the study. Patients will be assigned to one (1) of two (2) groups with the aim of attaining blood pressure control. Participants in group 1 will be assigned to renal denervation, participants in group 2 will receive additional antihypertensive medication according to current guidelines and best practice in an attempt to reach blood pressure targets.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Renal Denervation for Resistant Hypertension
Study Start Date : February 2012
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Renal Denervation Group
participants randomised to undergo the renal denervation procedure
Device: Renal Denervation
Renal Denervation Catheter
Other Name: Symplicity Renal Denervation Catheter

No Intervention: Usual care
participants randomised to the usual care group will receive additional antihypertensive medication in an attempt to achieve blood pressure targets



Primary Outcome Measures :
  1. blood pressure control [ Time Frame: 6 months post procedure ]
    percentage of patients to achieve Blood Pressure (BP) target (BP <140/90mmHg, or <130/80mmHg in diabetic patients) at 6 months post procedure


Secondary Outcome Measures :
  1. number of drugs required to reach blood pressure target [ Time Frame: baseline to 6 months ]
    number of drugs required to reach blood pressure target

  2. time to achieve blood pressure target [ Time Frame: baseline to 6 months ]
    time to achieve blood pressure target

  3. Change in markers of sympathetic nerve activity [ Time Frame: baseline to 6 months ]
    Changes in Muscle Sympathetic Nerve Activity (MSNA), renal and whole body Norepinephrine (NE) spillover

  4. Change in Left Ventricular Structure and Function [ Time Frame: baseline to 6 months ]
    Change in Left Ventricular mass index, ejection fraction, diastolic filling as assessed by echocardiogram

  5. Change in Quality of Life [ Time Frame: baseline to 6 months ]
    Change in Quality of Life as assessed by relevant questionnaires

  6. Serum and Urine Biochemistry [ Time Frame: baseline to 6 months ]
    Plasma renin activity, aldosterone, estimated Glomerular Filtration Rate (eGFR), urine albumin-to-creatinine ratio (UACR), inflammatory markers, 24hour urinary creatinine clearance, sodium, fasting glucose, fasting insulin, c-peptide, Homeostasis Model Assessment (HOMA) index, lipid profile

  7. Change in markers of arterial stiffness [ Time Frame: baseline to 6 months ]
    Change in markers of arterial stiffness including Augmentation Index (AI) and Pulse Wave Velocity (PWV)



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • systolic BP ≥140mmHg or ≥130mmHg for patients with diabetes
  • concurrent treatment with ≥3 anti-hypertensive drugs

Exclusion Criteria:

  • renal artery anatomy ineligible for treatment
  • eGFR <15mL/min/1.73m2 (using Modification of Diet in Renal Disease (MDRD) calculation)
  • female participants of childbearing potential must have negative pregnancy test prior to treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01865240


Locations
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Australia, Victoria
Baker IDI Heart & Diabetes Inst
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
Baker IDI Heart and Diabetes Institute
Investigators
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Principal Investigator: Markus Schlaich, MD Baker IDI Heart & Diabetes Institute

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Responsible Party: Baker IDI Heart and Diabetes Institute
ClinicalTrials.gov Identifier: NCT01865240    
Other Study ID Numbers: 008/12
NHMRC ( Other Grant/Funding Number: 1034397 )
First Posted: May 30, 2013    Key Record Dates
Last Update Posted: November 5, 2018
Last Verified: November 2018
Keywords provided by Baker IDI Heart and Diabetes Institute:
renal denervation
blood pressure
cardiovascular risk
target organ damage
sympathetic activity
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases